KOVA - KOVA LQT ABNORMAL 4X120ML - KOVA INTERNATIONAL, INC.

Duns Number:078780990

Device Description: KOVA LQT ABNORMAL 4X120ML

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More Product Details

Catalog Number

87177

Brand Name

KOVA

Version/Model Number

87177

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JJW

Product Code Name

Urinalysis Controls (Assayed And Unassayed)

Device Record Status

Public Device Record Key

f612048c-8444-4a46-90b1-ed21ef4b319d

Public Version Date

August 20, 2020

Public Version Number

1

DI Record Publish Date

August 12, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KOVA INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 114